Manager – Microbiology (OSD facility)

Acme Generics; Solan; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Acme Generics in India is seeking a senior Microbiology Manager to oversee the daily activities of the microbiology team within a USFDA-approved OSD facility. You will ensure cGMP/data integrity compliance and drive investigations related to OOS/OOT deviations.

The role requires 12–15 years of experience in regulated manufacturing, leadership skills, and the ability to coordinate cross-functional teams with QA, Production, and Engineering while maintaining strict laboratory standards.

Qualifications

• Master’s degree in Microbiology or equivalent with regulatory knowledge.
• 12–15 years of experience in a USFDA-approved OSD pharmaceutical manufacturing facility.

Responsibilities

• Plan, allocate, and supervise daily activities of the Microbiology team.
• Review microbiological test records, worksheets, and reports.
• Ensure timely execution of routine microbiological testing and environmental monitoring.
• Lead investigations for OOS, OOT, deviations, and contamination events; implement CAPA.
• Prepare and review SOPs, protocols, reports, and microbiology documentation.
• Coordinate with QA, Production, Engineering, and other departments for lab operations.
• Drive continuous improvement and ensure compliance of microbiology lab operations.
• Support audits by USFDA and other global agencies.
• Conduct training and competency assessment of microbiology personnel.
• Ensure availability of media, reagents, and lab resources.
• Maintain lab equipment calibration, qualification, and maintenance.
• Maintain laboratory housekeeping, safety, and regulatory compliance.

Skills

GMP compliance

Data Integrity

CAPA investigations

OOS/OOT investigations

Audit readiness

Team leadership

Regulatory liaison

Education

MSc in Microbiology

Job description

• Ensure compliance with gowning/de-gowning procedures as per SOPs.
• Ensure adherence to cGMP, GLP, and Data Integrity requirements.
• Plan, allocate, and supervise daily activities of the Microbiology team.
• Review microbiological test records, worksheets, and reports.
• Ensure timely execution of routine microbiological testing and environmental monitoring.
• Execute and review qualification, validation, and method validation activities.
• Prepare and review SOPs, protocols, reports, and microbiology documentation.
• Coordinate with QA, Production, Engineering, and other departments for smooth laboratory operations.
• Lead investigations for OOS, OOT, deviations, contamination events, and ensure effective CAPA implementation.
• Conduct training and competency assessment of microbiology personnel.
• Ensure availability of media, reagents, consumables, and laboratory resources.
• Ensure calibration, qualification, and maintenance of microbiology laboratory equipment.
• Maintain laboratory housekeeping, safety, and regulatory compliance.
• Support and represent the department during internal, customer, and regulatory audits (USFDA and other global agencies).
• Drive continuous improvement and ensure overall compliance of microbiology laboratory operations.

Qualification: M.Sc. in Microbiology

Experience: 12-15 years in a USFDA-approved OSD pharmaceutical manufacturing facility.